JP5345664B2 - Apparatus and method for delivering therapeutic agents to tissue - Google Patents

Description

  The present invention relates to a device for administering a therapeutic agent, in particular a gaseous therapeutic agent such as an oxidizing gas or an inert gas, to a tissue.

  Spine joint and tendon pain is a common illness that 80% of the world's population experiences once and has the potential to exacerbate the illness. In many cases, the cause of such pain is a degenerated disc that progresses to a disease known as a herniated disc. This occurs by compressing the spinal nerves by pushing the nucleus pulposus through the laceration or fissure in the outer line of the disc. Compression by a nucleus pulposus hernia leads to inflammation and causes pain in the lower limbs (known as sciatica). The treatment of this type of back pain varies depending on the severity of the hernia. In relatively mild cases, a sufficient amount of rest and weight of activity can reduce the condition. However, surgical intervention is recommended for critically ill patients with hernia or for patients who do not benefit from non-invasive treatment (pharmacotherapy and / or physical therapy). Such invasive therapies have drawbacks such as 1) irreversible treatment, 2) scar tissue formation, 3) slow recovery, 4) long term hospitalization required.

  Since 1950, treatment of sciatica and low back pain has been performed by percutaneous procedures to avoid surgery. Percutaneous discectomy and chemical nucleus fibrolysis are well known as percutaneous treatments, but researchers have continued to explore new alternatives due to the cost of treatment. In 1984, an Italian orthopedic surgeon, Dr. Cesare Verga proposed treatment of intervertebral hernia with an ozone / oxygen mixture (e.g., http: //www.cleananasociation1com/6/ca_3.htm, Ozone Therapeut: New breakthrough Met. Reference (cited in the present invention, Non-Patent Document 1)).

  Other prior art includes M.I. Muto and F.M. Avella, “Percutaneous Treatment of Herniated Lumbar Disc by Intramolecular Oxygen-Ozone Injection” (Interventional Neurological Intravenous Intervention of Non-Neural Intervention of the Intervertebral Discs, Non-Neural Intervention of the Intervertebral Discs, Non-Neural Intervention of the Intervertebral Nerve Discs 2).

  Rheumatoid arthritis, osteoarthritis, tennis elbows, forty shoulders and housework knees and other repetitive movement damage and inflammation due to sports and work, two surfaces including joint functions such as tendons, sheaths to move tendons and lubrication tubes Occur between. Inflammation, such as bursitis in the knees, shoulders, hips or anatomical sac, can be effected by the injection of therapeutic agents such as oxygen-ozone mixtures, excited energized pure oxygen, and epicondylitis and wrist, hand It is also effective for other tendonitis and bursitis including the tendon sheath of the hand and wrist. Inflammation occurs when tendons or ligaments are inserted into the bone or pass through the sheath due to trauma, pressure, overwork, disease, and the like.

  And inflammation spreads through joint pathologies of joint inflammation such as rheumatoid arthritis, psoriatic arthritis and osteoarthritis. Examples of joints that are readily amenable to injection of therapeutic agents such as oxygen-ozone mixtures and excited energized pure oxygen include synovial joints such as the mandibular joint, the hip joint, the knee joint, the ankle joint, the elbow joint, and the sacroiliac joint. It is effective for treating inflammation in small spine joints and sacroiliac joints. Also, such as hands, wrists, feet, etc., such as rheumatic joints, osteoarthritis, carpal tunnel syndrome, etc. Effective in treating joint inflammation.

  For the treatment of inflammation and arthritis or worsening of the above-mentioned conditions, an anti-inflammatory agent such as ibuprofen or a more powerful steroid or chemotherapeutic agent such as methotrexate is used in combination. The usual treatment involves injecting a steroid drug or lidocaine directly into the inflamed tissue or joint. And often this treatment is repeated. These drugs have side effects and can result in death from gastric ulcer bleeding or immunosuppressive infections. Therefore, a method using a gas or a gas-dissolved liquid such as an oxygen-ozone mixture and excitation-energy-purified pure oxygen is considered to be advantageous over the current treatment methods.

  To clean surgical sites before permanent surgical implantation, such as artificial hip bones, knees, pacemakers, and infected joints, use an oxygen-ozone mixture, pure energized oxygen as a sterilizing agent. Easy to use. Furthermore, when performing an artificial anus construction, by injecting a gas such as an oxygen-ozone mixture, excitation energy-purified pure oxygen, or a gas-dissolved liquid into the combined intervertebral disc, recovery can be assisted and infection can be prevented. Postoperative recovery of sternotomy in cardiac surgery can be problematic due to wound infection. Use an appropriate catheter to aid recovery by injecting an oxygen-ozone mixture, excitation energized pure oxygen. In practice, for a large number of wounds, a catheter having a large number of holes is used to inject an oxygen-ozone mixture, pure energized excitation energy. This method has effects such as anti-infection, analgesia, and wound healing, shortening the recovery time and reducing the complexity of the post-operative course.

  Gases or gas-dissolving liquids such as oxygen-ozone mixtures, excited energized pure oxygen, etc. can be used for wounds / surgery such as abdominal incisions such as appendectomy, emergency colonostomy such as colostomy, and endoscopic cholecystectomy Inject the surgical site into a highly infectious condition.

  Endoscopic percutaneous injection of ozone and percutaneous catheter injection of ozone can prevent complications in endoscopic medical treatment such as endoscopic examination of the pancreatic duct, imaging, and non-image guidance catheter medical treatment.

  Injection of a gas or gas-dissolved liquid, such as an oxygen-ozone mixture, excited energized pure oxygen, into the tooth promotes dental cavity repair and reduces root canal inflammation or periodontal disease.

  There are also veterinary applications in which animals with intervertebral disc injury and pathogenic syndromes are administered microinvasively with gases or gas-dissolved liquids such as oxygen-ozone mixtures, excited energized pure oxygen, and the like. Some other options are addressed by the place of animal activity. Some animals may die from secondary pain due to pain such as disc damage or arthritis.

  The potential for therapeutic agents such as oxygen-ozone mixtures and excitation-energized pure oxygen will expand as long as the investigation continues, but it is important as a therapeutic agent for disc herniation compared to other surgical and percutaneous treatments It is clear that it is effective. The effects are: 1) few therapeutic and neuroradiological contraindications, 2) success rate in disc treatment exceeds 70%, 3) no or short period for recovery, 4) side effects 5) No or little scar tissue formation, 6) Minimally invasive treatment possible, 7) No previous conservative treatment such as rest or working less As an alternative treatment.

  Ozone gas therapy is a non-invasive alternative therapy for the treatment of intervertebral disc herniation, and has continued to place importance on the medical field. It is far from. For example, SPM Recovery Technologies Ltd. (Http://www.spm.co.il), US Pat. No. 6,073,627 (Patent Document 1), and American Health Magazine (January 1988, page 16) all treat wounds with ozone. Is described. However, the devices disclosed therein are bulky, difficult to handle, too powerful, difficult to maintain, wash and calibrate, and expensive. Furthermore, these devices do not support aseptic methods that can selectively deliver ozone to an affected area such as a herniated disc. The gas is unstable and has a half-life of a few minutes. No medical ozone generator has been proposed that can be used by itself alone. Accordingly, there is a need for specially designed devices that can treat disc herniation with therapeutic agents such as oxygen-ozone mixtures, excitation energized pure oxygen, and other medically effective and sterile use. In addition, there is a need for a set of devices that are portable, disposable or reusable, can be sterilized, stable, and generate ozone immediately upon use for medical care in the worsening of inflammation and disease.

US Pat. No. 6,073,627

Gaetano Morello, M .; D. "Ozone Therapy: New breakthrough for Back Treatment", [online], Internet <URL: http: // www. cleananarassition1com / 6 / ca_3. htm> M.M. Muto and F.M. Avella, “Percutaneous Treatment of Hermetic Lumbar Disc by Intramolecular Oxygen-Ozone Injection”, Interventional Neurology 4

  Accordingly, it is an object of the present invention to provide a novel apparatus and method for injecting gas into tissue that eliminates or mitigates at least one of the disadvantages of the prior art described above.

  The gist of the present invention resides in a syringe comprising a cylinder and a plunger inserted into the first end of the cylinder, and capable of delivering a therapeutic drug from the second end of the cylinder. The syringe further includes a gas generator that is connected to either the plunger or the barrel and that produces the therapeutic agent. The syringe further includes an accumulator disposed in the cylinder and in communication with the gas generator so that the therapeutic agent produced from the gas generator can be accumulated and having an accumulation configuration. The accumulator has a configuration capable of delivering a substance from the second end of the cylinder. The accumulator automatically changes from a configuration capable of accumulating the therapeutic agent to a configuration for delivering the therapeutic agent when the amount of the manufactured therapeutic agent reaches a predetermined amount.

  The gaseous therapeutic agent is an oxidizing gas or an inert gas or a combination thereof.

Examples of the oxidizing gas include an oxidizing gas containing oxygen (O ₂ ), a mixture of oxygen and ozone (O ₃ ), oxygen radicals, hydroxy radicals, ionized oxygen, energy-treated oxygen, and combinations thereof.

  Inert gases include nitrogen, helium, carbon dioxide and combinations thereof.

  When the gas generator is a corona discharge ozone generator, the accumulator has an internal space in the cylinder and accumulates oxygen. The plunger has a DC power source (battery or the like) and an electric circuit, generates a high voltage, high frequency AC electric signal, and supplies it to the gas generator. The frequency of the high frequency electrical signal is about 10 to 1000 kHz, preferably about 20 to 60 kHz. The voltage of the high voltage electrical signal is about 1-20 kV, preferably about 3-6 kV. The ambient temperature is about 15-30 ° C, preferably about 20-25 ° C.

  The gas generator may be a UV light source, in which case the accumulator has an internal space in the cylinder and accumulates oxygen. The plunger has a DC power source (battery or the like) and an electric circuit, generates an electric signal, and supplies it to the UV light source. The wavelength of the UV light source is about 100 to 700 nm, preferably 140 to 200 nm.

  In another aspect of the present invention, the gas generator includes an open container for storing the ozonized gel and a heating member, and the operation of the heating member causes the oxygen-ozone mixed gas to be released from the ozonized gel. The temperature of the gel can be increased. The ozonized gel is formed by blowing ozone into olive oil and cooling it. The olive oil is cooled at about -15 to 10 ° C.

  Another aspect of the present invention is an ozone generator for generating a therapeutic oxygen-ozone mixed gas, the ozone generator having a connecting portion for fixing the gas generator to either a plunger or a cylinder. The cylinder has a first end for receiving the plunger and a second end for delivering ozone from the plunger upon pressurization of the plunger. The gas generator is connected to an accumulator arranged in a cylinder configured to store ozone. When the accumulator has an accumulation configuration, the oxygen-ozone mixed gas is accumulated in the accumulator. The accumulator further has a configuration capable of sending the oxygen-ozone mixed gas from the second end of the cylinder. The accumulator automatically changes from the storage configuration to the delivery configuration when the amount of the therapeutic oxygen-ozone mixture produced reaches a predetermined amount, and the therapeutic oxygen-ozone from the second end of the tube. Deliver mixed gas.

  The gas generator includes a container for storing the ozonized gel and a heating member, and the operation of the heating member raises the temperature of the ozonized gel so as to release the oxygen-ozone mixed gas from the ozonized gel.

  The gas generator is an electrochemical cell.

  The gas generator is a corona discharge device.

  The gas generator is a UV light source.

  The subject matter of the present invention further includes a method of generating a therapeutic agent and a method of administering the therapeutic agent using the device disclosed in the present invention.

  The present invention is a novel device that can administer a therapeutic agent, particularly a gaseous therapeutic agent such as an oxidizing gas or inert gas, to a tissue, eliminating or mitigating at least one of the disadvantages of the prior art.

The perspective view which shows one embodiment of the therapeutic agent administration apparatus of this invention Side view of the device shown in FIG. Sectional drawing seen through the dotted line of III-III of FIG. 2 at the time of using the porous membrane which is one embodiment of this invention The side view in the accumulation | storage state which the accumulator expanded in the apparatus shown in FIG. The side view in the accumulation | storage state which the accumulator further expanded in the apparatus shown in FIG. FIG. 5 is a side view of the apparatus shown in FIG. Graph of ozone gas released when 1g of ozonized olive oil is heated to 37 ° C Side view of an apparatus for administering a therapeutic agent according to another embodiment of the invention Side view of the device shown in FIG. 8 in the accumulation state The side view in the sending state of the apparatus shown in FIG. The side view which shows pushing down of a plunger in the delivery state of the apparatus shown in FIG. Side view of an apparatus for administering a therapeutic agent according to another embodiment of the invention Side view of an apparatus for administering a therapeutic agent according to another embodiment of the invention

  Hereinafter, although this invention is demonstrated using an Example and drawing, these are illustrations. FIG. 1 shows one embodiment of an apparatus 20 for delivering a therapeutic agent. The apparatus 20 has a needle (injection needle) 24 connected to a syringe 28, and the syringe 28 has a hollow cylinder 32 for inserting a plunger 36.

  The therapeutic agent in the cylinder 32 is delivered through the needle 24 by the pressure from the plunger 36. The needle 24 is made of a desired material and has a desired length and diameter so that a desired therapeutic agent can be delivered. In this embodiment, the syringe 28 delivers an oxygen-ozone mixture to the affected hernia. The needle 24 can be a Chiba needle, a France needle, or other needle known to those skilled in the art.

  The cylinder 32 is made of a material that is sufficiently rigid and inert when exposed to ozone, such as glass, stainless steel, polycarbonate, high density polyester, chlorinated polyvinyl chloride, silicon, ethylene-propylene terpolymer, Fluoropolymers such as polytetrafluoroethylene and fluorinated ethylene-propylene can be used. The tube 32 is substantially cylindrical and has a first end 40 and a second end 44 opposite thereto. The first end 40 is an opening 48 that can receive the plunger 36. The second end 44 has a cylindrical protrusion 52 outward from the second end 44, the outlet 56 has a diameter smaller than the diameter of the opening 48 of the first end 40, and the outlet 56 1 has a diameter smaller than the diameter of the opening 48 of the end 40, and can send out an oxygen-ozone mixed gas. The cylindrical protrusion 52 has a configuration in which the needle 24 can be attached.

The shaft 80 projects from the actuator 72 toward the second end 68. The shaft 80 has a cross-sectional structure that is crossed, and a power source is mounted in the same direction as the shaft 80. In this embodiment, the power source 84 is disposed closer to the actuator 72 between the first end 64 and the second end 68, the two batteries are disposed parallel to the shaft 80, and the shaft 80 cross members are arranged adjacent to each other. The power source 84 is connected to the switch 76 and the gas generator 88 by electric wires. When the switch 76 is on, current is sent to the gas generator, and when the switch 76 is off, no current flows through the gas generator 88. It has a configuration like this. The power supply 84 preferably supplies a current of about 1-30V, preferably about 5-10V.

  The plunger 36 is also preferably made of the above materials that are inert when exposed to ozone. The plunger 36 is substantially cylindrical so that it can be inserted concentrically with the tube 32, and has a first end 64 and a second end 68 opposite to the first end 64. The structure is such that it can be inserted into the opening 48. The first end 64 is pushed down by the surgeon or specialist. In the present embodiment, an on-off switch 76 is disposed at the center of the actuator 72. Of course, the switch 76 may be arranged in other positions, for example, other parts of the actuator 72 such as the circumferential part of the actuator 72, the surface of the tube 32, other parts connected to the syringe 28, etc. May be. The switch 76 can be moved back and forth between the “on” and “off” positions.

  The shaft 80 projects from the actuator 72 toward the second end 68. The shaft 80 has a cross-sectional structure that is crossed, and a power source is mounted in the same direction as the shaft 80. In this embodiment, the power source 84 is disposed closer to the actuator 72 between the first end 64 and the second end 68, the two batteries are disposed parallel to the shaft 80, and the shaft 80 cross members are arranged adjacent to each other. The power source 84 is connected to the switch 76 and the gas generator 88 by electric wires. When the switch 76 is on, current is sent to the gas generator, and when the switch 76 is off, no current flows through the gas generator 88. It has a configuration like this. The power supply 88 preferably supplies a current of about 1-30V, preferably about 5-10V.

  The gas generator 88 is disposed between the shaft 80 and the second end 68. In the embodiment of FIGS. 1 and 2 of the present invention, the gas generator 88 comprises an open system container 92 that stores the ozonated gel 96 and a porous membrane 100 that covers the opening end of the container 92. The gas generator 88 further includes a heating member 104 surrounding the container 92. The heating member 104 is connected to the power source 84 via the switch 76. When the switch 76 is on, the heating member 104 increases the temperature of the container 92 and its contents.

The gel 96 is composed of triacylated glycerin or triglycerin in which various combinations of fatty acids such as oleic acid, linoleic acid, and linolenic acid are bonded to a glycerin skeleton, or a general formula CH ₃ (CH ₂ ) _n COOH (n is about 12 Various combinations of fatty acids represented by (even number of ~ 20) are bonded to a glycerin skeleton. Olive oil (for example, CAS N.8001-25-0) is preferable, and ozone can be dissolved in the gel 96.

  The solubility of ozone in olive oil is about X mg as shown below for the amount of dissolved ozone per gram of olive oil. That is, per 1 g of olive oil, X is about 0.5 to 1.5, preferably about 0.7 to 1.2, particularly preferably about 1.

When the gel 96 is heated, ozone gas is released into the surrounding air, whereby a gaseous ozone mixture is generated, and Yμg of ozone shown below per 1 cm ³ of oxygen is delivered by the gaseous ozone mixture. That is, per cm ³ of oxygen, Y is about 5 to 100, preferably about 12 to 40, particularly preferably about 20.

  Gel 96 is prepared by blowing a gaseous oxygen-ozone mixture into olive oil until gelatinous and suitable for refrigeration. The refrigeration temperature is about 0-5 ° C. Gel 96 can be stored at refrigerated temperatures until use. The gel is once refrigerated and then placed in the container 92 of the gas generator 88.

  By heating the container 92 to the desired temperature using the heating member 104, the oxygen-ozone mixture is released from the gel 96. In this embodiment, the gas generator 88 is configured to heat the ozonized olive oil to about 20-80 ° C, preferably about 30-50 ° C, particularly preferably about 37 ° C.

  The container 92 has a closed structure at the end of the gas generator 88 close to the actuator 72, and has an open structure at the opposite end. The open end of the container 92 is covered by the porous membrane 100, and the gas generator 88 is continuous with the accumulator 108 that connects to the second end 68 of the plunger 36.

  As described above, the accumulator 108 is connected to the plunger 36 at the second end 68 and in this embodiment connected to the gas generator 88 via the porous membrane 100, the actuator 108 is elastic. It is made of a suitable deformable balloon or a suitable material that is inert and inflatable to ozone as exemplified by the cylinder 32. The accumulator 108 has a configuration capable of expanding from a non-expanded state as shown in FIG. 1 to an expanded state as shown by a dotted line in FIG. Further, the accumulator 108 has a configuration in which the accumulator 108 is pushed by the needle and the contents are delivered from the accumulator 108, and is in direct contact with the inside of the cylinder 32 (details will be described later). 1 and 2, the switch 76 is off, and the accumulator 108 is in the accumulation state. When the switch 76 is OFF, ozone gas is not substantially generated from the gas generator 88, and ozone gas is not substantially accumulated in the accumulator 108. Accumulator 108 is substantially unexpanded.

  FIG. 3 is a cross-sectional view taken along the dotted line III-III of the syringe 28 shown in FIG. 2, and the membrane 100 will be described in detail using this. The membrane 100 is disposed between the gas generator 88 and the accumulator 108 and has a hole 112 that is substantially circular. Through the holes 112, the ozone mixed gas generated from the gas generator 88 and moving from the gas generator 88 through the membrane 100 to the accumulator 108 is permeated. At this time, the remaining gel 96 remains in the gas generator 88. The diameter of the hole 112 shown in FIG. 2 is merely an example and does not represent a scale, and is a diameter that allows the gel 96 to remain in the container 92 and permeate the ozone mixture. In this embodiment, the membrane 100 comprises a porous ceramic or glass that is gas permeable and liquid is impermeable. In some embodiments, the membrane 100 can be omitted.

The device 20 is removed from the refrigerator compartment and operated before use. The plunger 36 is loaded into the opening 48 of the cylinder 32, and the needle 24 is attached to the protrusion 52 of the cylinder 32. As shown in FIG. 4, the switch 76 is turned on, and an electric circuit is formed by the power source 84. The power source 84 supplies a current for operating the heating member 104 through the electric wire. In operation, the heating member 104 heats the container 92 of the gas generator 88 and heats the gel 96 to raise the temperature as described above, but in this embodiment to about 37 ° C. The ozone mixture is released from the gel 96 by heating. The ozone mixture released from the gel 96 moves toward the opening of the container 92 and the membrane 100. Since the gel 96 does not remain in the container 92, the ozone mixture moves to the accumulator 108 through the holes 112 in the membrane 100. The ozone mixture is accumulated in the accumulator 108 and expands from the non-expanded state to the expanded state.

  FIG. 5 shows that with the switch 76 turned on, the ozone mixture continues to accumulate in the accumulator 108, and the accumulator 108 continues to expand toward the second end of the tube 32 and contacts the needle thrust member 60. Represents the state of being.

  FIG. 6 shows a state in which the accumulator 108 continues to expand toward the second end of the cylinder 32 and is pierced by the needle thrusting member 60 into the delivery state with the switch 76 further turned on. The ozone mixture is discharged from the accumulator 108 into the cylinder 32.

  When the cylinder 32 is filled with the ozone mixture, the switch 76 is turned off, and the ozone mixture is delivered from the apparatus 20 to the affected area. The needle 24 is inserted into the affected tissue of the patient (for example, a hernia site or other target site), and an ozone mixture is administered. After the needle 24 is inserted into the target site, the actuator 72 is pushed down in the direction of the second end of the cylinder 32 and the oxygen-ozone mixture is delivered from the cylinder 32 and delivered to the target site through the outlet 56 and the needle 24. The The graph shown in FIG. 7 represents the relationship between the amount of oxygen-ozone mixture released and time when a gel that can be suitably used as the gel 96 is heated. In this example, a plurality of 1 g samples of ozonized olive oil gel are prepared, to which 100 ml of indigo reagent (0.6 g / L potassium indigotrisulfonate dissolved in 20 mM phosphoric acid) is added, and about 21. Warmed to 5 ° C. The amount of ozone released after holding at 21.5 ° C. for about 7.5 hours is about 0.95 mg (ozone) / 1 g (olive oil) for an old gel after 6 months storage, and for a new gel after 24 days storage. About 0.85 mg (ozone) / 1 g (olive oil).

  The gas generator 88 described here is one example employed in the present invention, and any gas generator for producing an oxygen-ozone mixture can be used.

  An example of the gas generator 88 is an electrochemical ozone generation cell comprising an anode, a cathode, a cation exchange membrane, and an electrolyte. Oxygen and ozone are produced at the anode and the oxygen-ozone mixture is released from the electrochemical cell via the electrolyte water. The voltage at the preferred current used is about 3-20V, preferably about 2-10V, and the temperature is about 5-50 ° C, preferably about 15-30 ° C.

  An application form of the device 20 is shown as a device 20a in FIGS. Since the device 20a has many components that are the same as those of the device 20, the reference numerals of the components are the same as those shown in FIG.

  The major difference between the device 20 and the device 20a is that there is no balloon accumulator connected to the gas generator 88a and that the tube 32a does not have a needle pushing member. Further, as will be described in detail below, the inner side 116 a of the cylinder 32 a has a shape different from the inner side surface of the cylinder 32. That is, the inner side 116a of the cylinder 32a is disposed in the cylinder 32a and has a second end 120a different from the second end 44a of the cylinder 32a. Furthermore, the difference from the device 20 is that the device 20a movable stopper 124a is provided on the inner side 116a of the tube 32a. The device 20a also has an outlet passage 128a and a vent port 132a disposed within the tube 32a. Furthermore, the gas generator 88a of this embodiment has a structure different from that of the gas generator 88 of the apparatus 20 (although it is not necessary to change the gas generator in other embodiments), the heating member, gel, membrane Or do not have a container. The gas generator 88a is a corona discharge device, an electrochemical ozone generation cell, a UV light source, or a combination thereof.

  FIG. 8 is a diagram in which the inner side 116a of the cylinder 32a is arranged coaxially from the first end 40a in the cylinder 32a toward the second end 44a of the cylinder 32a. The inner side 116a of the tube 32a is substantially cylindrical, and the second end 120a is disposed between the first end 40a and the second end 44a of the tube 32a. The second end 120a is near the second end 44a of the tube 32a.

  The movable stopper 124a is disposed on the inner side 116a of the cylinder 32a. The movable stopper 124a is elastic and deformable, is made of a suitable material such as that described for the plunger 36, has a disk shape, and its outer diameter is slightly larger than the inner diameter of the inner side 116a of the cylinder 32a, A normal plunger protrusion has the same structure as a normal structure that complements the inside of a normal syringe barrel. The stopper 124a is in close contact with the inner side 116a of the cylinder 32a to form a substantially airtight structure, from the vicinity of the first end 40a of the cylinder 32a to the direction near the second end 120a of the inner side 116a of the cylinder 32a. I can move. Further, the stopper 124a divides the inner side 116a of the cylinder 32a into a first chamber 136a and a second chamber 140a.

  The first chamber 136a is formed in the inner side 116a of the cylinder 32a between the stopper 124a and the second end 68a of the plunger 36a. The second chamber 140a is formed in the inner side 116a of the cylinder 32a between the stopper 124a and the second end 120a of the inner side 116a of the cylinder 32a. The first chamber 136a is connected to the gas generation chamber 88a via the nozzle at the second end 68a of the plunger 36a. Along with the movement of the stopper 124a, the first chamber 136a can expand in the length direction of the inner side 116a of the cylinder 32a, takes a storage structure, and accordingly, the second chamber 140a shrinks. When the first chamber 136a has a storage structure, only the second chamber 140a communicates with the outlet passage 128a connected to the inner wall of the inner side 116a of the cylinder 32a near the second end 120a of the inner side 116a of the cylinder 32a. Have Further, when the first chamber 136a has a delivery structure, the stopper 124a is located near the second end 120a of the inner side 116a of the tube 32a, and the first chamber 136a and the outlet passage 128a are in communication.

  The outlet passage 128a has an inlet 144a and an outlet 148a disposed in the cylinder 32a and a passage 152a connecting them. The inlet 144a of the outlet passage 128a is near the second end 120a of the inner side 116a of the cylinder 32a and between the first end 40a of the cylinder 32a and the second end 120a of the inner side 116a of the cylinder 32a. It is arranged on the side wall of the inner side 116a. The outlet 144a of the outlet passage 128a is disposed in the protruding portion 52a. The passage 152a has a substantially hollow and tubular configuration and is formed along the side wall of the cylinder 32a from the inlet 144a toward the second end 44a, across the base of the cylinder 32a at the second end 44a, It reaches the exit 148a in the direction of the protrusion 52a. The air vent port 132a is composed of an inlet (shown but not labeled), an outlet (shown but not labeled), and a passage disposed in the cylinder 32a connecting them. . The inlet of the air vent 132a is disposed at the base of the inner side 116a of the tube 32a of the second end 120a. The outlet of the air vent 132a is disposed on the side wall of the cylinder 32a between the second end 120a of the inner side 116a of the cylinder 32a and the second end 44a of the cylinder 32a. The passage of the air vent 132a has a substantially hollow and tube-like configuration, and is directed from the inlet of the air vent 132a to the second end 44a via the base of the tube 32a, and at the second end 44a, the tube 32a It is formed across the base and toward the outlet of the air vent 132a.

  In order to move the device, the plunger 36a is loaded into the opening 48a of the cylinder 32a, and the needle 24a is mounted on the protrusion 52a of the cylinder 32a. FIG. 9 shows the apparatus at the start of operation, wherein the first chamber 136a is in the storage state, and the stopper 124a is disposed between the first end 40a of the tube 32a and the outlet of the passage 128a, and the second chamber 140a communicates only with the exit of the passage 128a. The switch 76a is turned on, and an electric circuit is formed by the power source 84a. The power source 84a supplies a current to the gas generator 88a via an electric wire. In operation, the gas generator 88a generates an oxygen-ozone mixture and is discharged into the first chamber 136a on the inner side 116a of the cylinder 32a via the nozzle of the plunger 36a at the second end 68a. FIG. 10 is a diagram illustrating a state in which the first chamber 136a is filled with the oxygen-ozone mixture generated by the gas generator 88a. The stopper 124a is formed by the oxygen-ozone mixture stored in the first chamber 136a. Pressed in the direction of the second end 120a with pressure. The stopper 124a is pushed in the direction of the second end 120a of the inner side 116a of the cylinder 32a by the pressure of the stored oxygen-ozone mixture, and the first chamber 136a expands, so that the second chamber 140a is located inside the cylinder 32a. Reduce along 116a. Since the second chamber 140a shrinks, the air in the second chamber 140a is discharged from the air vent port 132a. If the switch 76a continues to be on, the stopper 124a continues to move in the direction of the second end 120a of the inner side 116a of the cylinder 32a, and the first chamber 136a changes from the storage state to the delivery state as shown in FIG. The first chamber 136a communicates with the outlet passage 128a.

  As shown in FIG. 11, when the first chamber 136a is filled with the oxygen-ozone mixture and enters the delivery state, the switch 76a is turned off, and the oxygen-ozone mixture is delivered from the device 20a to the affected area. The needle 24a is inserted into the affected tissue of the patient (for example, a hernia site or other target site), and an oxygen-ozone mixture is administered. After the needle 24 is inserted into the target site, the actuator 72a of the plunger 36a is pushed down in the direction of the second end 120a of the inner side 116a of the tube 32a, and the oxygen-ozone mixture is delivered from the first chamber 136a and exited. It is delivered to the target site through the passage 128a and the needle 24a.

  A device to which the device 20a is applied is shown in FIG. Since the device 20b has the same components as the device 20a, the reference numerals of the components are indicated by the same numbers and the suffix b. The major difference from the device 20a is that the gas generator 88a of the device 20a is coupled to the plunger 36a, whereas the gas generator 88b of the device 20b is disposed on the outer surface of the barrel 32b of the syringe 28b. is there.

  Furthermore, an apparatus to which the apparatus 20a is applied is shown in FIG. An application type of the gas generator 88, which includes a corona discharge device 88c made of a dielectric 87c and an electrode 89c. The corona discharge device 88c produces oxidizing gas. For example, the corona discharge device 88c releases an oxygen-containing gas into the inner side 116c of the cylinder 32c. The evolved gas can be pure oxygen. For example, the oxygen-ozone mixture is released from the corona discharge device 88c by passing an oxygen-containing gas through the electric field of the corona discharge device 88c. The electric field of the corona discharge device 88c flows at a frequency of about 1 to 20 kV, preferably 3 to 6 kV at a frequency of about 10 to 1000 kHz, preferably 20 to 60 kHz, and about 15 to 30 ° C., preferably 20 to 25. Form at a temperature of ° C. A power source that supplies the above frequency and voltage (or other parameters) is supplied by a power source 84 and causes the gas generator 88c to generate an electrical signal in accordance with these parameters. The power supply 84c is turned on / off by a switch 76c.

  In use, the device 20c is in the form shown in FIG. Next, the switch 76c is turned on, and the gas generator 88c derives an electric field and reacts with oxygen in the inner side 116c of the cylinder 32c to generate ozone. When the ozone generation cycle is established, the plunger 36c is pushed down to send out ozone from the end of the cylinder 32c. In the present embodiment, the stroke of the plunger 36c is pushed down to the extent that it does not come into contact with the end of the cylinder 32c.

  It should be understood that the configuration of the gas generator 88c is merely exemplary and other shapes of corona discharge devices can be used.

  In the present description, examples in which various gist and component are specifically combined are shown. However, those skilled in the art can easily understand that the disclosed gist and component and a desired partial configuration of the combination can be used. For example, other diseases can be treated in the present invention. In addition, other parts such as joints, tendons, and ligaments can be treated. Furthermore, it can be treated with a therapeutic agent for relieving pain in the wound part, for example, healing of the wound part in colostomy. It can also be treated in sterilization such as a subcutaneous sac holding a pacemaker and / or pain relief and / or treatment of inflammation, treatment with other therapeutic agents and treatment as would be performed by one skilled in the art. Furthermore, not only oxygen-ozone mixtures can be used as therapeutic agents, but also other active agents known to those skilled in the art.

  Further, it should be understood that the device of the present invention can take any desired size or shape. Moreover, in the specific embodiment of this invention, it has a hollow cylinder which can receive a plunger and a plunger slidably. Here, it should be considered that the plunger and barrel of the device can have the desired complementary size and shape. It is also clear that the components of this embodiment can be combined in various ways. For example, either the plunger 36 or the plunger 36a can be combined with the cylinder 32 and the cylinder 32a.

  Further, it should be understood that the gas generator in the present invention can take any desired size, shape and form. For example, in the above embodiment, a gas generator having an ozonated gel (for example, the gas generator 88), a corona discharge device, an electrochemical cell, a UV light source, or the like is used as the gas generator. Other gas generators suitable for producing a shaped therapeutic agent can also be used.

  The gaseous therapeutic agent is an oxidizing gas or an inert gas or a combination thereof.

Examples of the oxidizing gas include an oxidizing gas containing oxygen (O ₂ ), a mixture of oxygen and ozone (O ₃ ), oxygen radicals, hydroxy radicals, ionized oxygen, energy-treated oxygen, and combinations thereof.

  Inert gases include nitrogen, helium, carbon dioxide and combinations thereof.

  Also, the gas generator can be placed in any suitable location associated with the syringe of the device. For example, the gas generator can be used in any device such as any location between the first end and the second end of the plunger, any location between the first end and the second end inside the tube, etc. It can be placed in any suitable location on the syringe. In addition, the gas generator can be placed at a suitable location on the outer surface of the syringe (see FIG. 12), or it can be placed outside the syringe so as to communicate without being connected to the syringe.

  It should be understood that the accumulator in the above embodiment and the first chamber in the above embodiment can take any desired size, shape and form. For example, in the above embodiment, the accumulator is exemplified by an elastic and deformable balloon. However, other forms such as a bag, a container, a container, and a chamber are possible as long as the accumulator can be changed from a storage state to a delivery state. . Furthermore, the first chamber in the present invention may have any configuration as long as it can change from the storage state to the delivery state. It should also be understood that the power source in the present invention can take any desired size, shape and form. For example, in the above embodiment, the power source consists of two batteries, the two batteries being adjacent to the actuator shaft between the first and second ends of the plunger and adjacent to the cross member of the plunger shaft. Although arranged in parallel to the shaft in close proximity to, other embodiments are possible. For example, one or more batteries in any shape, at any position between the first and second ends of the plunger, between the first and second ends of the barrel, outside the syringe It can be placed on the surface. Moreover, the power supply which exists in the exterior of a syringe and can be connected with a syringe at the time of ozone generation may be sufficient. Similarly, a heating member and a power source may be omitted if the syringe can heat the ozone generator via an external heat source to generate an oxygen-ozone mixture.

  Furthermore, it should be understood that in the above embodiments, the outlet passage can take any desired size, shape and form. For example, the entrance of the exit passage can be located at any suitable location between the first and second ends on the space side of the tube. Furthermore, the passage of the outlet passage may be formed outside the side wall of the cylinder, may be formed inside the side wall of the cylinder, or may be formed in both.

  Furthermore, it should be understood that in the above embodiments, the air vent port can take any desired size, shape and form. For example, the inlet of the air vent port may be at any suitable location on the inner base of the cylinder at the second end of the cylinder, at any suitable location on the inner sidewall of the cylinder between the stopper and the second end of the cylinder. Can be placed. Further, the outlet of the air vent port can be disposed on the side wall of the cylinder between the first and second ends of the cylinder, the base of the cylinder at the second end of the cylinder, the protruding portion of the cylinder, and the like.

  Although the embodiments of the present invention have been described above, it is obvious that various modifications can be made to the above-described embodiments without departing from the gist of the present invention. Should be limited.

20: Device 20a: Device 20b: Device 20c: Device 24: Needle 24a: Needle 28: Syringe 28b: Syringe 32: Tube 32a: Tube 32b: Tube 32c: Tube 36: Plunger 36a: Plunger 36c: Plunger 40: First End 40a: First end 44: Second end 44a: Second end 48: Opening portion 48a: Opening portion 52: Protruding portion 52a: Protruding portion 56: Outlet 60: Needle thrusting member 64: First end 68 : Second end 68a: Second end 72: Actuator 72a: Actuator 76: Switch 76a: Switch 76c: Switch 80: Shaft 84: Power supply 84a: Power supply 84c: Power supply 87c: Dielectric 88: Gas generator 88a : Gas generator 88b: Gas generator 88c: Corona discharge device 89c: Electrode 92: Open system vessel 96: Sonized gel 100: Porous membrane 104: Heating member 108: Accumulator 112: Hole 116a: Inside of tube 32a 116c: Inside of tube 32c 120a: Second end 124a: Movable stopper 128a: Outlet passage 132a: Vent port 136a : First chamber 140a: second chamber 144a: inlet 148a: outlet 152a: passage

Claims (7)

An ozone generator for generating a therapeutic oxygen-ozone mixed gas, the ozone generator having a connecting portion for fixing the gas generator to either a plunger or a cylinder, the cylinder being a first for receiving the plunger have a second end for delivering the ozone from the plunger by the pressure end and a plunger, a gas generator is connected to the accumulator later-arranged in the cylinder that is configured to store the ozone, the accumulator later- Has a configuration capable of delivering to a position having a flow path relationship at the second end, and the accumulator is manufactured by being expanded toward the second end by the manufactured therapeutic oxygen-ozone mixed gas. When the amount of the therapeutic oxygen-ozone mixed gas reaches a predetermined amount, the configuration is such that the therapeutic oxygen-ozone mixed gas is accumulated from the configuration capable of accumulating the therapeutic oxygen-ozone mixed gas. In automatically changed, therapeutic oxygen from the second end of the cylinder - an ozone generator characterized by having a structure that allows sending ozone gas mixture.   The gas generator includes a container for storing the ozonized gel and a heating member, and the temperature of the ozonized gel is increased by operating the heating member so as to release the oxygen-ozone mixed gas from the ozonized gel. A gas generator according to 1.   The gas generator according to claim 1, wherein the gas generator is an electrochemical cell.   The gas generator according to claim 1, wherein the gas generator is a corona discharge device.   The gas generator according to claim 1, wherein the gas generator is a UV light source. A manufacturing method of a gaseous treatment agent, placing the accumulator later-having storage structure syringe in the cylinder to generate a therapeutic agent in accumulator lay the coater, the step of Ru inflating the accumulator later-in the cylinder, A method for producing a gaseous therapeutic agent, comprising: a step in which an accumulator automatically changes from a storage state to a delivery state in a cylinder when the amount of the gaseous therapeutic agent reaches a predetermined amount. A cylinder, a plunger inserted into the first end of the cylinder and for delivering a drug from the second end of the cylinder, and oxygen connected to a corona discharge device for generating an oxidizing gas from oxygen during storage. A syringe comprising an accumulator disposed in a cylinder having a storable configuration, wherein the accumulator is expanded toward the second end in the cylinder by the gaseous therapeutic agent produced ; A syringe having a gas delivery structure capable of delivering a gaseous therapeutic agent in an accumulator from a second end when the amount of the therapeutic agent reaches a predetermined amount.

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